MAUDE Adverse Event Report: TIDI PRODUCTS LLC AG-SB, 7X7, PACKAGE; TAPE AND BANDAGE, ADHESIVE

Model Number 50010-PKG

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This information was obtained from an amazon review.The device is unavailable for evaluation and information is limited to that which was contained within the review.Aquaguard is a one use, non-sterile product.The complaint rate over the past two years including amazon review feedback is (b)(4), with no medical interventions or serious incidents reported to date.There have been no incidents or evidence to suggest if a wound or surgical site were to become wet from a shower that a serious incident, infection, medical intervention, or death would occur.The instructions for use were reviewed and appear to be adequate for use of this product.Aquaguard is intended for showering only and is not recommended for submersion underwater.Aquaguard is not a replacement for primary dressings.For best results, a caregiver should apply the aquaguard product to the patient.Apply aquaguard to clean dry skin.Do not use lotion or cream before applying.Do not lift and/or attempt to reposition aquaguard after placement.Do not use if punctured or showing signs of wear.Please reference instructions for use (ifu) or ifu video for application details.If reused, it may not provide an effective barrier while showering.(b)(4).

Event Description

Amazon review may 8 2022: so i had major low back surgery.I have been unable to get my back and bandage wet and thought this would help with showers.Nope.The 7x7 is actually 5x5 and does not actually stick well.There has not been one shower that my bandages have stayed dry using even two of these protectors.Luckily my insurance is now covering a medical supply version and the home health agency has had a box sent to my home.2-3 months of cat bathing will not be nice and repeated exposure of my spine to water and air during too early changing of dressing is too scary to chance.One wrong move and i get an infection directly in my spine.This product was not sufficient for protection.

• Brand Name: AG-SB, 7X7, PACKAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14651399
• MDR Text Key: 301507863
• Report Number: 2182318-2022-00070
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50010-PKG
• Device Catalogue Number: 50010-PKG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1